EU RAC Exam- Question with Correct Answers Provided (100% Guaranteed Pass)

First course of action to market a new class III medical device technology in the shortest time is... - Answer- to collect required clinical data Instructions for Use language is defined by the Member State. Having a local distributor is not a mandatory requirement. - Answer- Transposed Meidcal Devices Directive. If the Essenntial Requirements are met by stating conformance to a standard and the standard is revised, the changes must be evaluated to ensure conformance with the standard can still be demonstrated. - Answer- Directive 93/42/EC Directive states that any new therapeutic class of active substances must follow the centralized procedure. - Answer- Director 2004/27/EC The Notified Body is responsible for assessing parts of hte Conformity Assessment Procedures applied by manufacturers under commercial contracts - Answer- MEDDEV 2.4/1 If a manfuacturer is unsure how its devices should be classified, it should: - Answer- consult a notified body Notified Body - Answer- in the European Union, is an organisation that has been accredited by a Member State to assess whether a product meets certain preordained standards. Assessment can include inspection and examination of a product, its design and manufacture. For example, a Notified Body may designate that a medical device conforms to the EU Medical Devices Directive, which defines the standards for medical devices. With this Declaration of Conformity, the manufacturer can label the product with the CE Mark, which is required for distribution and sale in the EU. Significant changes to an Annex II list A IVD should be documented int he design dossier and reported to the notified body - Answer- on a continuous basis The applicant shall inform the Notified Body that issued the EC design examination certificate of any signficant change made to the approve design - Answer- In Vitro Devices Directive (98/79/EC) Annex III Abridged Application - Answer- an application for marketing authorization that, based upon demonstrating essential similarity or by detailed references to published scientific